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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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dash 3 enfit syringe, dash 3 eccentric enfit syringe, dash 3 plus enfit syringe, dash 3 plus eccentric enfit syringe, dash 3 enfit low dose tip syringe Intervene Group Limited k170371 10/20/2017
aution jet aj-4270 urine analyzer International Remote Imaging Systems k030600 07/11/2003
mp4000 series ii compact video imager International Imaging Electronics k900901 04/30/1990
implantable pulse generator pacemaker Intermedics, Inc. k791417 09/04/1979
model 493-01 pacing lead Intermedics, Inc. k844263 03/28/1985
il test(tm) urea nitrogen Instrumentation Laboratory CO k914877 03/11/1992
i.m. arthroscope Instrument Makar, Inc. k821847 07/22/1982
nail splint Inro Medical Designs, Inc. k850803 10/16/1985
ist anterior cervical plate system Innovative Spinal Technologies, Inc. k072650 11/28/2007
mte-t radiogrphic/tomographic elevating table Imt America, Inc. k903921 12/04/1990

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